Actively Recruiting
Multimodal Physiotherapy Based on Tele-rehabilitation in Chronic Pelvic Pain Associated With Endometriosis
Led by University of Alcala · Updated on 2024-01-17
66
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether a tele-rehabilitation program can reduce chronic pelvic pain and improve quality of life in women with endometriosis. The study compares a program combining pain education, therapeutic exercise, and respiratory control to a control group receiving only informational materials about their condition. Researchers will assess changes in pain, catastrophizing, fear of movement, sexual function, and overall health. Women in the experimental group will participate in 20 online sessions over 8 weeks via the TRAK platform, including 16 therapeutic exercise and breathing sessions and 4 pain education sessions. Sessions occur 2 to 3 times per week, varying by week. The control group receives educational materials about lifestyle and endometriosis during weeks 1, 3, 5, and 7 but does not access the exercise or breathing videos. Participants will complete several questionnaires before treatment, immediately after, and at 3 and 6 months post-intervention to measure outcomes like pain, sexual function, quality of life, anxiety, depression, physical activity, sleep quality, and stress. Researchers will also monitor adherence and global impression of change. The total participation period includes these assessments to track lasting effects and safety.
CONDITIONS
Brief Title
Multimodal Physiotherapy Based on Tele-rehabilitation in Chronic Pelvic Pain Associated With Endometriosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with a medical diagnosis of endometriosis.
- Age between 18 and 55 years.
- Have received medical and/or surgical treatment with controlled disease.
- Persistent pelvic pain lasting at least 3 months.
- Pain level greater than 4 on the Visual Numeric Scale.
- No cognitive impairments affecting consent or understanding.
- Access to an electronic device (tablet, computer, cell phone).
- Have a valid email address.
You will not qualify if you...
- Peri- and postmenopausal women.
- Women who are pregnant or planning pregnancy during the study.
- History of gynecologic cancer or current oncologic treatment in the pelvic area.
- Diagnosis of chronic fatigue or fibromyalgia.
- Participation in another intervention study at the same time.
- Undergoing surgery during the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive either an 8-week tele-rehabilitation program with 20 online physiotherapy sessions or informational materials about their condition and healthy lifestyle habits.
20 online sessions for the TeleRehab Group; informational materials delivered in weeks 1, 3, 5, and 7 for the Advices Group
Duration - Up to 5 months post-intervention
Participants are assessed at 2, 3, and 5 months after the end of treatment to monitor health status, pain, quality of life, physical activity, sleep quality, stress, and treatment adherence.
Assessments at post-intervention (2 months from baseline), and at 3 and 5 months post-intervention
Trial Site Locations
Total: 1 location
1
Physiotherapy in women´s health research group. University of Alcalà
Alcalà de Henares, Madrid, Spain, 28871
Actively Recruiting
Research Team
M
María Torres-Lacomba, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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